KindredBio. Best Medicines for Our Best Friends

Transcription

1 KindredBio Best Medicines for Our Best Friends 1

2 Forward Looking Statements This presentation contains forward-looking statements, including but not limited to statements regarding the timing of development for our product candidates, expected commencement and completion of pivotal trials, prospective product candidates, anticipated regulatory approvals for our product candidates, anticipated commercialization of our product candidates, our financial position, business strategy, plans and objectives of management for future operations and other similar statements. These forward-looking statements are based on our current expectations and beliefs, as well as assumptions concerning future events. These statements are subject to risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including, but not limited to, our limited operating history and lack of profitability, our lack of product revenue and potential need to raise additional capital to achieve our goals, our dependence upon the success of our lead product candidates, other companies ability to develop substantially similar products that may compete with our product candidates, any inability to obtain regulatory approval for our existing or future product candidates, any delay or discontinuance of our current or future pivotal trials, any inability to achieve market acceptance or commercial success for our product candidates even if they are approved, inability to obtain adequate intellectual property protection covering our product candidates, our dependence on third-party manufacturers for supplies, and any inability to successfully identify, develop and commercialize additional product candidates. Any forward-looking statement made by us in this presentation speaks only as of the date of this presentation and represents our estimates and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these statements publicly, or to update the reasons actual results could differ materially from those anticipated in these statements, even if new information becomes available in the future. 2 March 15, 2016

3 We Love Our Pet Family Members Annually, U.S. pet parents estimated to spend: $15.7 billion on veterinary care $1.5 billion on dog knee surgeries $370 million on pet Halloween costumes $700 million on Valentine s Day gifts 3

4 KindredBio Bring the very best science and medicine to our animal family members. 4

5 KindredBio s Strategy: Repurpose Human Drugs for Pets Pursue molecules already known to work Reduce technical risk Reduce timelines $3M-$5M to develop each pet drug Reduce financing risk Portfolio approach 5

6 KindredBio Highlights Attractive Markets Rapidly growing Few current competitors Strategic Approach Reduces technical risk Reduces financing risk World Class Team Extensive drug development experience Human and veterinary experience Deep Pipeline ~20 small molecule and biologic candidates Two launches by 2017 KIND-012 for fever in horses KIND-010 for weight loss in cats 2+ launches per year thereafter 6

7 World Class Leadership Team Richard Chin, M.D. Founder and Chief Executive Officer Former Head of Clinical Research, BioTherapeutics, Genentech Rhodes Scholar Denise Bevers Founder and Chief Operating Officer Founder, SD Scientific; 25 years in biotech/pharma Stephen Sundlof, D.V.M, Ph.D. Chief Scientific Officer and Executive Vice President, Regulatory Affairs & Quality Former Director, Center for Veterinary Medicine, FDA Wendy Wee Vice President, Finance 16 years of biotechnology finance experience Hangjun Zhan, Ph.D. Vice President, Biologics Research 20 years of drug discovery experience 7 7

8 Deep Product Pipeline Molecule Indication Formulation Small Molecule Product Candidates Laboratory Pilot Studies Field Pilot Studies Pivotal Clinical Study NADA & Launch Preparation KIND-010 Management of weight loss in cats KIND-012 Fever in horses Rolling NADA Being Filed KIND-014* KIND-015* Equine gastric ulcer syndrome Metabolic syndrome in horses Molecule Indication Discovery/Process Development Biologic Product Candidates Pilot/Pivotal Clinical Studies NADA & Launch Preparation Feline Epo Anti-Interleukin Antibodies Checkpoint Inhibitors Anti-CD20 antibody KIND-Bodies KIND-502 Anti-IgE antibody KIND-501 Anti-VEGF antibody Anemia in cats Atopic dermatitis in dogs Cancer in dogs Cancer and autoimmune diseases in dogs Multiple indications Allergic diseases in dogs Cancer in dogs * Initial pilot studies completed. Final formulation being developed. 8

9 Key Strengths Validated, repurposed molecules Avoid risks associated with new chemical entities Reduced costs and timelines, including for API No royalties/milestones Expertise in biologics In-house clinical development capabilities Reduced costs and timelines by not having to rely on CROs Focus on lean cost structure and efficiency Strong cash position 9

10 10 Market Opportunity

11 Veterinary Market is Growing Rapidly $18 $16 $15.7 $14 Spending in Billions $12 $10 $8 $6 $4 $9.3 The veterinary care market grew 70% from 2006 to 2015 $2 $ Estimated Source: APPA Pet Industry Market Size & Ownership Statistics 2015 & TriMark Vet Health Market, June

12 There is a High Willingness to Pay Pet owners are willing to spend on their seriously ill pets if they require medical treatment $500 $1,000 $2,000 $5,000 Extremely/Very likely 62% 42% 35% 22% Somewhat likely 18% 20% 28% 20% Not too likely/not at all likely 18% 36% 36% 55% Don t know 1% 2% 1% 3% Source: The AP-Petside.com Poll, Conducted by GfK Roper Public Affairs & Media; Interview dates: April 7 April 12,

13 But Treatment Options are Limited Underserved market with attractive growth opportunities Few competing biotechs Large pharma focused on blockbusters On average, less than a dozen pet drugs are approved annually by the FDA In 2015 the FDA approved: 0 novel pet drugs 45 novel humans drugs 13

14 Veterinary Pharmaceuticals Field Pet Therapeutics Many years behind Human Pharmaceuticals We believe there are similarities between veterinary pharmaceutical field now and the human pharmaceutical field in its early stages: Similar regulatory standards Similar commercial and reimbursement landscape Similar development costs Numerous untapped opportunities (low hanging fruit) 14

15 Veterinary vs. Human Markets Can reach market in 3-5 years Faster Development Lower Development Cost Can develop for $3M-$5M per product Very few reimbursement hurdles Self-Pay Lower Competition Almost no biotechs, almost no generics 15

16 16 Programs

17 KindredBio Strategy Small Molecules Already validated in humans & established manufacturing Customize speciesspecific dosage and formulate flavored/convenient delivery Biologics Targets based on approved human drugs (e.g., Enbrel and Orencia) Create canine/ feline/equine versions of biologics with the same or similar target 17

18 KindredBio s Priority Areas Equine Products High willingness to pay Similar to human orphan drug market Efficient commercial structure Biologics Atopic dermatitis Cancer 18

19 Equine Market Fewer horses than cats or dogs, but higher willingness to pay similar to human orphan drug markets Only sales representatives required for full national coverage Underappreciated opportunity KindredBio s goal is to become dominant company in the equine sector 19

20 Zimeta (dipyrone injection, KIND-012) IV and oral drug for treating fever in horses High unmet medical need IV: Oral: Over 50% of equine veterinarians treat 1-3 fevers per month (~35% treat 6-10 fevers per month) Positive pilot study completed Positive pivotal field study completed CMC technical section of NADA filed Dec 2015 Effectiveness technical section of NADA filed Feb 2016 Safety technical section of NADA filed Mar 2016 Formulation development ongoing Initial pilot studies underway 20

21 Zimeta Pilot Study Results (IV) Randomized, blinded, placebo-controlled, crossover study (N=31) Primary endpoint was improvement or resolution of fever Response First dose Placebo KIND-012 n Response Rate (%) 2 (12.5) 10 (66.7) p-value Response Crossover Dose Placebo KIND-012 n Response Rate (%) 0 (0) 8 (57.1) p-value

22 Zimeta Pilot Study Results (IV) Mean Temp. over Time - First Dose and Crossover Dose (Treated Pts.) 22

23 Zimeta - Pivotal Field Study Results (IV) KB0120 study: Randomized, double-blind, placebo-controlled (N=138) Primary endpoint was improvement or resolution of fever Placebo Zimeta n Success Rate (%) 7 (20.6) 78 (75.0) p-value <

24 KIND-010 Transdermal drug for the management of weight loss in cats High unmet medical need Current drugs often not effective 90% of veterinarians treat cats with inappetence (average of 7 cats per week) PK studies completed - positive efficacy signal, as evidenced by increase in weight Pilot study completed - positive efficacy signal, as evidenced by increase in weight Pivotal field study underway 24

25 Biologics Highly experienced biologics team Extensive experience developing Lucentis, Xolair, Tysabri, Avastin, Rituxan, Herceptin, Enbrel, and multiple other biologics Internal caninization/felinization/equinization expertise Promising biologics candidates Feline erythropoietin Checkpoint inhibitors Interleukin antibodies New technologies, including KIND-Bodies 25

26 New Scaffold Technology: KIND-Body A proprietary, non-antibody scaffold technology being developed by KindredBio Binding affinity similar to antibodies Bispecific binding possible Could allow KindredBio to pursue biologics targets before other parties antibody patents expire 26

27 KIND-510 Feline Erythropoietin Proprietary recombinant feline erythropoietin Strong internal expertise in erythropoietin biology and engineering Initial laboratory study completed - positive efficacy signal, as evidenced by increased reticulocyte formation Pilot field study ongoing High unmet medical need Up to 30% of elderly cats (over 15 years) develop kidney failure, leading to anemia Human erythropoietin is immunogenic in cats 27

28 Key Focus Area: Atopic Dermatitis Atopic dermatitis is a large market Apoquel projected peak sales >$200M Multiple antibody candidates Anti-IgE antibody Anti-IL17a antibody Anti-IL4Ra antibody Anti-IL31 antibody Anti-CD20 antibody Expect proof-of-concept data with some of the initial antibody variants potentially as early as this year 28

29 Key Focus Area: Cancer Multiple antibody candidates Anti-CTLA4 antibody Anti-PD1 antibody Anti-PDL1 antibody Anti-CD20 antibody 29

30 Strategic Shift Toward Biologics Will increase biologics headcount and increase laboratory space Counterbalanced by headcount reduction in other areas, including small molecule CMC ($655K restructuring charge in Q1) Expect annual cash burn to remain at approximately $25M per year 30

31 Manufacturing Plant In-house biologics manufacturing plant nearly complete Single-use, state of the art system Will allow full GMP commercial production of feline epo Will allow full GMP clinical and early commercial production of antibodies 31

32 32 Commercialization

33 Commercialization Equine Commercialization: Launch and commercialize our U.S. products with ~10 person direct sales force Dog/Cat Commercialization Options: Self-Commercialization Out-license Partner for 3 5 years, and then transition to KindredBio salesforce 33

34 Low Generic Penetration Generic dispensing rates 90% 80% 70% 60% 50% 40% 30% 20% 10% 7% 81% Few pet generic companies No automatic substitution Requires sales & marketing effort Rimadyl reached peak sales several years after loss of exclusivity 0% Companion Animal Human Note: Companion Animal dispensing rate within the veterinary clinic. Source: IMS Health, Putney, BofA Merril Lynch Global Research 34

35 Exclusivity and IP Position Full intellectual property protection anticipated for antibody portfolio Use and formulation patents for small molecules 20 years of patent protection from date of filing Regulatory Exclusivity 5 years in U.S. 10 years in E.U. Lifecycle Management New formulations, combinations and derivatives 35

36 Business Development In active discussions about acquisitions of businesses and/or assets, particularly of equine assets Ideal candidate: Revenue generating/accretive Commercial infrastructure Complementary assets 36

37 37 Finances

38 Select Summary Financials $ millions Operating expenses: For the quarter ended December 31, 2015 Research and development $4.6 General and administrative $1.9 Total cash operating expenses (excluding stock-based compensation) Total operating expenses (including stock-based compensation) Total cash, cash equivalents and investments (As of December 31, 2015) $5.4 $6.5 $77.6 We believe that our cash and equivalents are sufficient to fund operations until we start generating significant revenues. 38

39 Summary Validated Drugs and Targets $3M-$5M to Market World Class Team Multiple Approvals Starting within 1 year 39

40 40 Thank You